desogestrel
Regulatory sources consulted
Approved indications
- Progestin-only oral contraception.
Contraindications
Absolute
- Active venous thromboembolism.
- Severe liver disease until liver function normalizes.
- Sex-steroid-sensitive neoplasm, undiagnosed vaginal bleeding, or hypersensitivity.
Clinical warnings
- Major warning · Safety and efficacy have not been established in adolescents younger than 18 years; no data are available. — CIMA/AEMPS, ficha técnica 76226
- Major warning · Irregular bleeding is very common and does not itself imply lower effectiveness; assess if heavy or prolonged. Consider ectopic pregnancy with amenorrhea and abdominal pain. — CIMA/AEMPS, ficha técnica 76226
- Major warning · Assess breast cancer, thrombosis, and liver disease history or risk before and during use. — CIMA/AEMPS, ficha técnica 76226
Drug interactions
- HighEnzyme inducers such as rifampicin, carbamazepine, phenytoin, topiramate, or St John’s wort
Mechanism: They increase hormone clearance and may cause bleeding or contraceptive failure.
Recommendation: Use a barrier method during treatment and for 28 days afterward; for long-term treatment, choose another method.
CIMA/AEMPS, ficha técnica 76226https://cima.aemps.es/cima/dochtml/ft/76226/FT_76226.html
Adverse events
Common (≥1%)
Irregular bleeding or amenorrhea · Acne · Mood changes or depression · Decreased libido · Headache · Nausea · Breast pain · Weight gain
Rare but serious
Anaphylaxis or angioedema · Venous thromboembolism
Pregnancy and lactation
It is not indicated during pregnancy; discontinue if pregnancy occurs. It may be used while breastfeeding, although infant growth and development should be monitored.
Recent literature (PubMed)
Many factors must be considered and discussed with women when initiating a contraceptive method and the risk of venous thromboembolism (VTE) is one of them. In this review, we discuss the numerous strategies that have been implemented to reduce the thrombotic risk associated with combined oral contraceptives (COCs) from their arrival on the market until today. Evidences suggesting that COCs were associated with an increased risk of VTE appeared rapidly after their marketing. Identified as the main contributor of this risk, the dosage of the estrogen, i.e., ethinylestradiol (EE), was significantly reduced. New progestins were also synthetized (e.g., desogestrel or gestodene) but their weak androgenic activity did not permit to counterbalance the effect of EE as did the initial progestins such as levonorgestrel. Numerous studies assessed the impact of estroprogestative combinations on hemostasis and demonstrated that women under COC suffered from resistance towards activated protein C (APC). Subsequently, the European Medicines Agency updated its guidelines on clinical investigation of steroid contraceptives in which they recommended to assess this biological marker. In 2009, estradiol-containing COCs were marketed and the use of this natural form of estrogen was found to exert a weaker effect on the synthesis of hepatic proteins compared to EE. In this year 2021, a novel COC based on a native estrogen, i.e., estetrol, will be introduced on the market. Associated with drospirenone, this preparation demonstrated minor effects on coagulation proteins as compared with other drospirenone-containing COCs. At the present time, the standard of care when starting a contraception, consists of identifying the presence of hereditary thrombophilia solely on the basis of familial history of VTE. This strategy has however been reported as poorly predictive of hereditary thrombophilia. One rationale and affordable perspective which has already been considered in the past could be th
Meta-analyses have reported conflicting data on the safety of hormonal contraception, but the quality of evidence for the associations between hormonal contraceptive use and adverse health outcomes has not been quantified in aggregate. To grade the evidence from meta-analyses of randomized clinical trials (RCTs) and cohort studies that assessed the associations between hormonal contraceptive use and adverse health outcomes among women. MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched from database inception to August 2020. Search terms included hormonal contraception, contraceptive agents, progesterone, desogestrel, norethindrone, megestrol, algestone, norprogesterones, and levonorgestrel combined with terms such as systematic review or meta-analysis. The methodological quality of each meta-analysis was graded using the Assessment of Multiple Systematic Reviews, version 2, which rated quality as critically low, low, moderate, or high. The Grading of Recommendation, Assessment, Development and Evaluations approach was used to assess the certainty of evidence in meta-analyses of RCTs, with evidence graded as very low, low, moderate, or high. Evidence of associations from meta-analyses of cohort studies was ranked according to established criteria as nonsignificant, weak, suggestive, highly suggestive, or convincing. A total of 2996 records were screened; of those, 310 full-text articles were assessed for eligibility, and 58 articles (13 meta-analyses of RCTs and 45 meta-analyses of cohort studies) were selected for evidence synthesis. Sixty associations were described in meta-analyses of RCTs, and 96 associations were described in meta-analyses of cohort studies. Among meta-analyses of RCTs, 14 of the 60 associations were nominally statistically significant (P ≤ .05); no associations between hormonal contraceptive use and adverse outcomes were supported by high-quality evidence. The association between the use of a levonorgestrel-releasin
Estrogen dependence and progesterone resistance play a crucial role in the origin and development of endometriosis. Therefore, hormonal therapies are currently the most effective treatment. Progestins are considered the first-line approach, especially for a long-term management. Progestins are synthetic compounds that mimic the effects of progesterone by binding progesterone receptors. Continuous use of progestins leads to the suppression of ovarian steroidogenesis with anovulation and low serum levels of ovarian steroids, causing endometrial pseudodecidualization. Moreover, they act by interfering on several endometriosis pathogenetic pathways, decreasing inflammation, provoking apoptosis in endometriotic cells, stimulating atrophy or regression of endometrial lesions, inhibiting angiogenesis, and decreasing expression of metalloproteinases, thus diminishing the invasiveness of endometriotic implants. Progestins are effective for pain relief and improvement of the quality of life (QoL). The side effects are limited, and the compounds are available in different formulations and routes of administration and represent, in most cases, an inexpensive treatment option. Dienogest, Medroxyprogesterone acetate and Norethisterone acetate are the labeled progestins for endometriosis, but other progestins, such as Dyhidrogesterone, Levonorgestrel and Desogestrel, have been shown to be effective in the treatment of endometriosis-associated pain. The present review aims to describe the available and emerging evidences on progestins used for the treatment of endometriosis.
Endometriosis (EMs) is a common gynaecological condition with high recurrence rates after fertility-preserving laparoscopic surgery, and optimal postoperative medical treatment remains unclear. To evaluate the efficacy and safety of various postoperative medical treatments in reducing recurrence, pain and adverse events in EMs patients after fertility-preserving surgery. PubMed, Web of Science, CENTRAL and Embase databases searched until August 1, 2024. Randomised controlled trials (RCTs) involving women aged 20-45 years post-fertility-preserving laparoscopic surgery, comparing single postoperative medications with a minimum follow-up of 2 months. Two reviewers independently extracted data and assessed quality using ROB 2.0 and CINeMA. Bayesian network meta-analysis calculated odds ratios (OR) and mean differences (MD) for recurrence rates, VAS pain reduction and adverse events. Sixteen RCTs (n = 1605 participants) evaluated 10 drugs: danazol, desogestrel, dienogest, gestrinone, goserelin, leuprolide, LNG-IUS, medroxyprogesterone, oral contraceptives and triptorelin. Only LNG-IUS significantly reduced recurrence rates (OR 0.12, 95% CI 0.02-0.63) and showed the greatest reduction in VAS pain scores (MD -24.96, 95% CI -41.76 to -8.75). Danazol significantly increased weight gain, and goserelin increased hot flashes. LNG-IUS combined with laparoscopic surgery appears most effective in reducing recurrence and pain in EMs patients. Danazol and goserelin should be used cautiously due to notable adverse effects.